EFPIA Laments 'Unfortunate' Exclusions From ICH Guide On Nonclinical Pediatric Safety
Europe’s research-based pharmaceutical industry has suggested changes to the draft ICH S11 guideline on nonclinical safety studies for supporting pediatric development programs.
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A new international guideline on non-clinical safety testing in support of pediatric drug development aims to cut unnecessary use of animals.
Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.
The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.